Dialysis Catheter

ABSTRACT

A dialysis catheter is provided. A first lumen extends through a first tubular member from a proximal portion to a distal portion, and a first orifice at the distal portion provides an opening through the first tubular member to the first lumen. The first tubular member further includes an inflation lumen extending longitudinally at least partially through a length of the first tubular member. A balloon is operably connected to an outer surface of the first tubular member proximal to the first opening, is in fluid communication with the inflation lumen. A second tubular member has a proximal portion connected to the outer surface of the first tubular member. A distal portion of the second tubular member is connected to the balloon wall. A second lumen extends through the second tubular member, and a second orifice provides an opening through the second tubular member at the distal portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/959,835, filed on Dec. 4, 2015, now pending, which is incorporatedherein by reference.

BACKGROUND OF THE DISCLOSURE

Dialysis catheters are used for varying durations in patients undergoinghemodialysis. Such catheters may be used for periods of time varyingfrom days (or less) to an indefinite period of time—i.e., weeks, months,or longer. Such catheters are used to exchange blood to and from ahemodialysis machine when the patient is undergoing treatment. Once atreatment session is complete, the catheter is disconnected from themachine and left inserted in the patient until the next session.

Between treatment sessions, a patient's body may create clots or otherthromboid obstructions at the catheter. Similarly, a fibrin sheath mayform around the catheter lumens within the body. Such thrombus andfibrin sheaths create poor performance when a technician attempts to usethe catheter during the next treatment. Blood flow through the cathetercan be partially or completely restricted. Partially restricted flowcauses extended treatment sessions which are problematic for thepatient, who must sit through a long session, and the clinic, which mustmake available additional equipment and personnel to attend to thelonger sessions. This results in additional costs to both the patientand the clinic.

If blood flow through the catheter is completely restricted orrestricted to where use of the catheter is impractical, the cathetermust be replaced. This requires the scheduling and use of a surgicalfacility and additional medical staff, including a surgeon, to replacethe device. Furthermore, the surgery and the introduction of a newcatheter brings a greater possibility of infection than the riskassociated with continued use of an existing catheter.

For this reason, there is a long-felt need for a dialysis catheter whichis usable despite obstructions and/or has allows a user to clearobstructions once they have formed.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure may be embodied as a dialysis catheter. Thecatheter has a first tubular member with a proximal portion and a distalportion. A first lumen extends longitudinally through the first tubularmember. A first orifice at the distal portion of the first tubularmember provides an opening through the first tubular member to the firstlumen. The first tubular member further includes an inflation lumenextending longitudinally at least partially through a length of thefirst tubular member. A balloon is operably connected to an outersurface of the first tubular member proximal to the first opening. Theballoon has a balloon wall at least partially surrounding the firsttubular member. The balloon is configured for disrupting occludingmaterial when occluding material is present near the distal portion ofthe catheter. The inflation lumen is in fluid communication with theballoon such that the balloon may be selectively inflated or deflated byway of the inflation lumen. The catheter also has a second tubularmember with a proximal portion connected to the outer surface of thefirst tubular member. A distal portion of the second tubular member isconnected to the balloon wall. A second lumen extends through the secondtubular member, and a second opening connects the second lumen at thedistal portion of the second tubular member.

Embodiments of the presently disclosed device provide catheters whichcan clear obstructions such as, for example, thrombosis/fibrin, from thedistal end in order to enhance blood flow into and/or out of thecatheter. Using such a catheter also allows for cost savings because theability to clear obstructions will reduce the need to replace obstructedcatheters.

DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the disclosure,reference should be made to the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1A depicts a dialysis catheter according to an embodiment of thepresent disclosure, wherein the balloon is shown inflated;

FIG. 1B depicts the dialysis catheter of FIG. 1A shown with the balloondeflated;

FIG. 1C is an end view of the dialysis catheter of FIGS. 1A and 1B;

FIG. 2A depicts a dialysis catheter according to another embodiment ofthe present disclosure, wherein the balloon is shown inflated;

FIG. 2B depicts the dialysis catheter of FIG. 2A shown with the balloondeflated;

FIG. 2C is an end view of the dialysis catheter of FIGS. 2A and 2B;

FIG. 3A depicts a dialysis catheter according to another embodiment ofthe present disclosure, wherein the balloon is shown inflated;

FIG. 3B depicts the dialysis catheter of FIG. 3A shown with the balloonpartially deflated;

FIG. 4 is an end view of a dialysis catheter according to anotherembodiment of the present disclosure;

FIG. 5 is an end view of a dialysis catheter according to anotherembodiment of the present disclosure;

FIG. 6 depicts a dialysis catheter according to another embodiment ofthe present disclosure, wherein the balloon is shown inflated;

FIG. 7 depicts a dialysis catheter according to another embodiment ofthe present disclosure, wherein the balloon is shown inflated;

FIG. 8 depicts a dialysis catheter having stylets according to anotherembodiment of the present disclosure, wherein the balloon is showndeflated and a stylet balloon is shown inflated;

FIG. 9 depicts a dialysis catheter having stylets according to anotherembodiment of the present disclosure, wherein the balloon is showndeflated and two stylet balloons are shown inflated;

FIG. 10 depicts a balloon stylet according to another embodiment of thepresent disclosure; and

FIG. 11 depicts a dialysis catheter according to another embodiment ofthe present disclosure, wherein the balloon is shown inflated.

DETAILED DESCRIPTION OF THE DISCLOSURE

With reference to FIGS. 1A-1C, the present disclosure can be embodied asa dialysis catheter 10. The catheter 10 has a first tubular member 12with a proximal portion 14 and a distal portion 16. A first lumen 18extends longitudinally through the first tubular member 12. A firstorifice 19 at the distal portion 16 of the first tubular member 12provides an opening through the first tubular member 12 to the firstlumen 18. The first opening 19 is depicted at an end of the firsttubular member 12, however it may be positioned in other locations onthe tubular member 12 at the distal portion 16 (i.e., near the distalend). The first tubular member 12 further includes an inflation lumen 20extending longitudinally at least partially through a length of thefirst tubular member 12.

The catheter 10 has a balloon 25 operably connected to an outer surface13 of the first tubular member 12. The balloon 25 is positioned distallyon the length of the first tubular member 12 and proximate the firstopening 19. The balloon 25 has a balloon wall that surrounds orpartially surrounds the first tubular member 12 along a portion of thelength of the member 12. The inflation lumen 20 is in fluidcommunication with the balloon 25 such that the balloon 25 may beselectively inflated or deflated. In some embodiments, when inflated,the balloon 25 increases in a transverse diameter with respect to thelongitudinal length of the first tubular member 12. When deflated, theballoon 25 is preferably configured to reduce in diameter such that adiameter of the catheter 10 at a position including the balloon 25 isnot significantly greater than a diameter of the catheter 10 at apositon which does not include the balloon 25. In this way, by inflatingthe balloon 25, occluding material, such as, for example, a fibrinsheath formed at the distal portion of the catheter 10 can be disruptedsuch that blood flow through the catheter 10 can be improved. Theballoon 25 can be inflated in way known in the art, for example, theballoon 25 may be inflated by injecting saline into the balloon 25 byway of the inflation lumen 20.

The balloon 25 may be generally shaped as a sphere, or have a longerdimension such that the balloon 25 is more ovoid in shape. Other shapesfor such balloons are known and within the scope of the presentdisclosure. The balloon 25 may be made of an elastomeric material suchthat the balloon wall is capable of stretching when the balloon 25 isinflated. In other embodiments, the balloon is made from a material thatgenerally does not stretch when the balloon is inflated.

The catheter 10 includes a second tubular member 30 having a primaryportion 32 connected to the outer surface 13 of the first tubular member12 and a distal portion 34 connected to an outer surface 26 of theballoon wall. The second tubular member 30 has a second lumen 31extending longitudinally therethrough. The distal portion 34 of thesecond tubular member 30 has a second opening 36 connected to the secondlumen 31 (i.e., second orifice 36 at the distal portion 34 of the secondtubular member 30 provides an opening through the second tubular member30 to the second lumen 31.) The second lumen 31 is sized for use withdialysis. As such, the second lumen 31 should allow for a flow rate ashigh as 200 to 800 ml/min or more.

The catheter 10 may further comprise a third tubular member 40 having aprimary portion 42 connected to the outer surface 13 of the firsttubular member 12 and a distal portion 44 connected to an outer surface26 of the balloon wall. The third tubular member 40 has a third lumen 41extending longitudinally therethrough. The distal portion 44 of thethird tubular member 40 has a third opening 46 connected to the thirdlumen 41. The third lumen 41 is sized for use with dialysis. As such,the third lumen 41 should allow for a flow rate as high as 200 to 800ml/min or more. In some embodiments, the third tubular member 40 extendsdistally beyond the second tubular member 30. In such cases, the thirdopening 46 can be located at a longitudinal position which is furtherdistal than the second opening 36.

In some embodiments, such as the catheter 510 depicted in FIG. 6. Thesecond tubular member 530 and the third tubular member 540 are connectedsuch that such that the second lumen 531 is in fluid communication withthe third lumen 541. In this way, the second and third lumen areaccessible by way of a proximal port.

While generally, catheter balloons will expand and contract by changingdiameter (i.e., changing size in the radial direction), in someembodiments of the present disclosure, a balloon 225 of a catheter 200is configured to extend longitudinally when inflated and retractlongitudinally when deflated. At least a portion of the balloon 225 maybe a bellows, may have pleats, and/or may be otherwise configured toretract in a longitudinal direction.

In some embodiments of catheters according to the present disclosure,the a tubular member may be flared such that a distal opening of thetubular member has a cross-sectional area which is greater than thecross-sectional area of the tubular member over a majority of itslength. In this way, the proclivity of an opening to become obstructedby, for example, a thrombosis/fibrin, is reduced. For example, FIG. 4shows a distal-end view of a catheter 300 having a first tubular lumen312, a second tubular member 330, and a third tubular member 340. Theends of the second and third tubular lumens have been flared (i.e., thesecond opening 336 and the third opening 346 have been flared) such thatthe cross-sectional area at the opening is greater than thecross-sectional area of the corresponding lumen (shown in dotted lines).In particular, it can be seen in the figure that the second opening 336has an area when viewed from an end (i.e., the cross-section area) thatis greater than the cross-sectional area of the second lumen over amajority of its length (shown as dotted line 331). Similarly, thirdopening 346 is shown as having a cross-sectional area that is greaterthan the cross-sectional area of the third lumen (dotted line 341).

FIG. 5 shows a distal-end view of a catheter 350 having no third tubularmember—similar to the catheter depicted in FIGS. 2A-2C. In catheter 350,it can be seen that the second tubular member 380 has an opening 386which is flared to have a larger cross-sectional area than that of thesecond lumen 381. In this embodiment, it can also be seen that the firsttubular member 362 has a flared opening (first opening 369) which has alarger cross-sectional area than that of the first lumen (dotted line368).

FIG. 7 depicts another embodiment of a catheter 550 wherein the tubularmembers include more than one opening. For example, it can be seen thatthe second tubular member 580 has a second opening 586 which comprisesmultiple openings. Similarly, the third tubular member 590 has thirdopening 596 which comprises multiple openings. It should be noted thatthe multiple openings need not be aligned on the respective tubularmembers and may be positioned at differing locations along the lengthand/or around the circumference of the tubular member.

Catheters of the present disclosure may further comprise one or morestylets. Such stylets are configured to be disposed through a lumen ofthe catheter in order to occlude the lumen (and the correspondingopening) when the catheter is not in use. In this case, the term “inuse” means that the catheter remains installed in an individual, but thecatheter is not being used to transfer fluids. By disposing a styletthrough the lumen, the stylet can be removed and the lumen and openingare unobstructed. FIG. 8 depicts a catheter 610 having a stylet disposedthrough each lumen (except for the inflation lumen). For example, thethird tubular member 640 has lumen 641 through which third stylet 645 isdisposed. In can be seen in the figure that the tip end 646 of the thirdstylet 645 emerges from the opening of the third lumen 641. Otherconfigurations are comprehended within the present scope where the tipend of a stylet does not emerge through the corresponding opening, or,in other cases, extends for some distance beyond the correspondingopening.

Stylets may include additional features that enhance the function of acatheter. For example, first tubular member 612 has a first lumen 613through which a stylet 615 is disposed. The tip end 616 of the stylet615 can be configured to detect the presence of bacteria or otherpathogens. For example, tip end 616 may include an indicator 617configured to indicate the presence of bacteria. In this way, the stylet615 may be used by a medical technician to quickly detect whether aninfection has occurred. As such, the infection may be quickly addressedrather than waiting for more gross indications of infection, which maybe at a time where the infection is more difficult to treat. Theindicator 617 may be a reactive substance which changes color orfluoresces at the indicator location. In other embodiments, theindicator may be remote (e.g., at a proximal end of the stylet, outsideof the patient's body) and may indicate that bacteria is detected at thedistal end of the stylet.

In other stylets, a balloon is disposed at the distal end of the styletso that obstructions may be cleared by inflating the stylet balloon. Forexample, in exemplary catheter 610 depicted in FIG. 8, the secondtubular member 630 includes a second lumen 631 through which stylet 635has been inserted. The stylet 635 comprises stylet balloon 637. In thiscase, stylet 635 may be hollow or may further comprise an inflationlumen such that stylet balloon 637 may be operably inflated. Whencatheter 610 is not in use, the stylet 635 may be inserted through thesecond lumen 631 and the stylet balloon 637 may remain deflated. Whenthe catheter 610 is about to be used, the stylet balloon 637 can beinflated and deflated to break up any obstructions, such as, athrombosis/fibrin, and then the stylet 635 can be removed from thesecond lumen 631. The stylet balloon 637 may remain within the secondlumen 631 when deflated and then pushed beyond the opening of the secondlumen 631 before inflation. In other embodiments, the stylet 635 may beconfigured to extend beyond the opening of the second lumen even whenthe stylet balloon 637 is deflated. Combinations of stylet features canbe used. For example, a stylet can include both an indicator forinfection and a stylet balloon.

In another example depicted in FIG. 9, catheter 650, the second tubularmember 680 includes a second lumen 681 through which stylet 685 has beeninserted. The stylet 685 comprises stylet balloon 687. In this case,stylet 685 may be hollow (e.g., may further comprise an inflation lumen)such that stylet balloon 687 may be operably inflated. Similarly, stylet695 is disposed through a third lumen 691. Stylet 695 includes a balloon697. When catheter 650 is not in use, the stylets 685,695 may beinserted through their respective lumens 681,691 and the stylet balloons687,697 may remain deflated. When the catheter 650 is about to be used,one or more of the stylet balloons 687,697 can be inflated and deflatedto break up any obstructions, such as, a thrombosis/fibrin, and then thestylets 685,695.

In another aspect of the present disclosure, a balloon stylet 700 (see,e.g., FIG. 10) is provided. The balloon stylet 700 is configured forclearing obstructions from a catheter, for example, the stylet 700 maybe configured to clear thrombosis/fibrin from the distal end of acatheter. The balloon stylet 700 includes a shaft 710 and a balloon 720disposed on a distal end 712 of the shaft 710. The shaft has a lumen 714from a proximal end to the distal end 712 and terminating at an orificethrough the shaft 710 such that the balloon 720 may be inflated anddeflated by way of the lumen 714. In some embodiments, the lumen 714does not form a passageway throughout the entire longitudinal length ofthe shaft 710, but terminates at an orifice near the distal end 712(e.g., short of the distal-most end of the shaft 710). The balloonstylet 700 can be made from any suitable materials known for suchmedical devices. In an embodiment, the balloon stylet 700 is made from amaterial which has a stiffness greater than the stiffness of acorresponding catheter for which it is designed.

In another embodiment, a dialysis catheter 750 comprises a first tubularmember 760 having a proximal portion 761, a distal portion 767 and afirst lumen 762 extending longitudinally therethrough (see FIG. 11). Thedistal portion 767 includes a first opening 769 connected to the firstlumen 762. The first tubular member 760 further includes an inflationlumen 781 extending at least partially through the first tubular member760. The catheter 750 includes a balloon 775 operably connected to anouter surface of the first tubular member 760 proximal to the firstopening 769. The balloon includes a balloon wall 776 at least partiallysurrounding the first tubular member 760 and configured to disruptoccluding material when occluding material is present near the distalportion 767 of the catheter 750. The inflation lumen 781 is in fluidcommunication with the balloon 775 for selective inflation and deflationof the balloon 775.

The first tubular member 760 includes a second lumen 772 extendingtherethrough. The distal portion 767 of the first tubular member 760includes one or more second openings 786 connected to the second lumen772 and disposed at least partially through the balloon 775. In thisway, the second lumen 772 may be a part of the first tubular member 760and located centrally with respect to the balloon 775. In similarfashion, a third lumen 792 may extend through the first tubular member760, and the third lumen 792 may include one or more third openings 796connecting the third lumen 792 through the balloon 775 to the exteriorof the catheter 750.

Although the present disclosure has been described with respect to oneor more particular embodiments, it will be understood that otherembodiments of the present disclosure may be made without departing fromthe spirit and scope of the present disclosure. The following arenon-limiting sample claims intended only to further illustrate exemplaryembodiments.

1. A dialysis catheter, the catheter comprising: a first tubular memberhaving a proximal portion, a distal portion, a first lumen extendinglongitudinally therethrough and an inflation lumen extending at leastpartially through the first tubular member, the distal portioncomprising a first opening connected to the first lumen; a balloonoperably connected to an outer surface of the first tubular memberproximal to the first opening, the balloon having a balloon wall atleast partially surrounding the first tubular member and configured fordisrupting occluding material when occluding material is present nearthe distal portion of the catheter, wherein the inflation lumen is influid communication with the balloon for selective inflation anddeflation of the balloon; and a second tubular member having a proximalportion connected to the outer surface of the first tubular member and adistal portion connected to the balloon wall, the second tubular memberhaving a second lumen extending therethrough, the distal portion of thesecond tubular member having a second opening connected to the secondlumen.
 2. The catheter of claim 1, further comprising a third tubularmember having a proximal portion connected to the outer surface of thefirst tubular member and a distal portion connected to the balloon wall,the third tubular member having a third lumen extending therethrough,the distal portion of the third tubular member having a third openingconnected to the third lumen.
 3. The catheter of claim 2, wherein thethird tubular member extends distally beyond the second tubular member.4. The catheter of claim 3, wherein the third opening is located at alongitudinal position which is further distal than the second opening.5. The catheter of claim 2, wherein the second tubular member and thethird tubular member are connected at the proximal end such that thesecond lumen is in fluid communication with the third lumen.
 6. Thecatheter of claim 1, wherein the balloon is configured to extendlongitudinally when inflated and to retract longitudinally whendeflated.
 7. The catheter of claim 6, wherein the balloon has a bellowsportion.
 8. The catheter of claim 1, wherein the balloon is made from anelastic material.
 9. The catheter of claim 1, wherein a distal end ofthe second tubular member is flared such that the second opening has across-sectional area which is greater than a cross-sectional area of thesecond lumen over a majority of a length of the second lumen.
 10. Thecatheter of claim 1, wherein the second opening comprises a plurality ofopenings.
 11. The catheter of claim 1, further comprising a removablestylet configured to be inserted through the first lumen to occlude thefirst lumen and first opening when the catheter is not in use totransfer fluids.
 12. The catheter of claim 11, wherein the stylet has adistal tip configured to detect the presence of a pathogen.
 13. Thecatheter of claim 12, wherein the stylet has an indicator in operablecommunication with the distal tip, and the indicator is configured toindicate when bacteria is detected by the distal tip.
 14. The catheterof claim 11, wherein the stylet includes a stylet balloon at a distalend, the stylet balloon configured for selective inflation anddeflation.
 15. A dialysis catheter, the catheter comprising: a firsttubular member having a proximal portion, a distal portion, a firstlumen extending longitudinally therethrough and an inflation lumenextending at least partially through the first tubular member, thedistal portion comprising a first opening connected to the first lumen;a balloon operably connected to an outer surface of the first tubularmember proximal to the first opening, the balloon having a balloon wallat least partially surrounding the first tubular member and configuredfor disrupting occluding material when occluding material is presentnear the distal portion of the catheter, wherein the inflation lumen isin fluid communication with the balloon for selective inflation anddeflation of the balloon; and wherein the first tubular member furthercomprises a second lumen extending therethrough, the distal portion ofthe first tubular member having one or more second openings connected tothe second lumen and disposed through the balloon.
 16. The catheter ofclaim 15, wherein the first tubular member further comprises a thirdlumen extending therethrough, the distal portion of the first tubularmember having one or more third openings connected to the third lumenand disposed through the balloon.
 17. A balloon stylet for clearingobstructions from a catheter, the stylet comprising: a shaft configuredto be disposed through a catheter lumen of the catheter; a balloon at adistal end of the shaft; and a lumen disposed through the length of theshaft and terminating at an orifice at the balloon such that the lumenis in pneumatic communication with a volume of the balloon for selectiveinflation or deflation of the balloon; and wherein the shaft isconfigured to have a length longer than the length of the catheter lumensuch that the balloon may be inflated at a location beyond a distal endof the catheter lumen.